Why it was recalled
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Product description
LOSARTAN POTASSIUM TABLETS, USP 100 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3747-00
Lot numbers, UPCs & expiration codes
1178533A, 1178534A, 1178535A, 1178536A, 1178537A, 1178538A, 1178539A, 1178540A, 1178541A, 1178542A, 1178543A, 1178544A, 1178545A, 1178546A exp 03/2020
Where it was sold
Bulk product was distributed to one re-packager in California.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1102-2020
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 25, 2020
- FDA report date
- Apr 15, 2020
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-1102-2020, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 85306
- Address
- 400 Interpace Pkwy
- Code information
- 1178533A, 1178534A, 1178535A, 1178536A, 1178537A, 1178538A, 1178539A, 1178540A, 1178541A, 1178542A, 1178543A, 1178544A, 1178545A, 1178546A exp 03/2020
- Postal code
- 07054-1120
- Report date
- Apr 15, 2020
- Product type
- Drugs
- Recall number
- D-1102-2020
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Reason for recall
- CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- LOSARTAN POTASSIUM TABLETS, USP 100 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3747-00
- Distribution pattern
- Bulk product was distributed to one re-packager in California.
- Recall initiation date
- Mar 25, 2020
- Initial firm notification
- Center classification date
- Apr 7, 2020